NCT06597695 A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
| NCT ID | NCT06597695 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Juliana Zambrano, MD, MPH |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-23 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression
Eligibility Criteria
Inclusion Criteria: 1\. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider. Exclusion Criteria: 1. History of primary psychotic disorder, by history 2. History Bipolar I disorder, by history 3. Unstable complex PTSD, as assessed by study clinician 4. History of dissociative identity disorder 5. History of neurocognitive disorder 6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview 7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \<140/90 mmHg. 8. History of aortic dissection 9. History of myocardial infarction 10. History of aneurysm 11. History of hepatic impairment. 12. History of epilepsy 13. History of prior hypersensitivity to ketamine 14. Body Mass Index greater than 35 15. Body Mass Index less than 18.5 16. Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion 17. Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis 18. Inability to provide consent.
Contact & Investigator
Juliana Zambrano, MD
STUDY DIRECTOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06597695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06597695 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06597695 currently recruiting?
Yes, NCT06597695 is actively recruiting participants. Contact the research team at JZAMBRANO2@mgh.harvard.edu for enrollment information.
Where is the NCT06597695 trial being conducted?
This trial is being conducted at Chelsea, United States.
Who is sponsoring the NCT06597695 clinical trial?
NCT06597695 is sponsored by Juliana Zambrano, MD, MPH. The principal investigator is Juliana Zambrano, MD at Massachusetts General Hospital. The trial plans to enroll 10 participants.
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